Shuttle Pharma Expands Clinical Trial Site Enrollment for Phase 2 of Ropidoxuridine for Treatment of Patients with Glioblastoma
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has expanded its Phase 2 clinical trial for Ropidoxuridine, a radiation sensitizer for treating glioblastoma patients. The company has added two more site locations, bringing the total to four out of six planned sites ready to enroll patients. These include UVA Cancer Center, John Theurer Cancer Center, Allegheny Health Network Cancer Institute, and Miami Cancer Institute.
The trial targets IDH wild-type, methylation negative glioblastoma patients, aiming to improve outcomes for this aggressive brain cancer. Ropidoxuridine has received Orphan Drug Designation from the FDA. The study will initially enroll 40 patients, testing two dosage levels, with an additional 14 patients added later to achieve statistical significance. Shuttle Pharma expects the trial to be completed in 18 to 24 months.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ha ampliato il suo studio clinico di fase 2 per il Ropidoxuridina, un sensibilizzante alla radiazione per il trattamento dei pazienti affetti da glioblastoma. L'azienda ha aggiunto due nuove sedi, portando il totale a quattro su sei siti pianificati pronti per arruolare pazienti. Questi includono l'UVA Cancer Center, il John Theurer Cancer Center, l'Allegheny Health Network Cancer Institute e il Miami Cancer Institute.
Lo studio si concentra su pazienti con glioblastoma IDH wild-type e negativi alla metilazione, con l'obiettivo di migliorare gli esiti per questo aggressivo tumore cerebrale. Il Ropidoxuridina ha ricevuto la Designazione di Farmaco Orfano dalla FDA. Lo studio prevede inizialmente l'arruolamento di 40 pazienti, testando due livelli di dosaggio, con l'aggiunta di ulteriori 14 pazienti in seguito per raggiungere la significatività statistica. Shuttle Pharma prevede che lo studio venga completato in 18-24 mesi.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ha ampliado su ensayo clínico de fase 2 para el Ropidoxuridina, un sensibilizador a la radiación para tratar a pacientes con glioblastoma. La empresa ha añadido dos ubicaciones más, llevando el total a cuatro de seis sitios planificados listos para inscribir pacientes. Estos incluyen el UVA Cancer Center, el John Theurer Cancer Center, el Allegheny Health Network Cancer Institute y el Miami Cancer Institute.
El ensayo se dirige a pacientes con glioblastoma tipo salvaje IDH y negativos a la metilación, con el objetivo de mejorar los resultados para este agresivo cáncer cerebral. El Ropidoxuridina ha recibido la Designación de Medicamento Huérfano de la FDA. El estudio inicialmente inscribirá a 40 pacientes, probando dos niveles de dosificación, con la adición de 14 pacientes más más tarde para alcanzar la significación estadística. Shuttle Pharma espera que el ensayo se complete en 18 a 24 meses.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH)는 뇌종양 환자를 치료하기 위한 방사선 감감제인 로피독수리딘의 2상 임상 시험을 확장했습니다. 이 회사는 두 개의 추가 연구 사이트를 추가하여 총 6개 예정된 사이트 중 4개가 환자 등록을 준비 완료했습니다. 여기에는 UVA 암 센터, John Theurer 암 센터, Allegheny Health Network 암 연구소 및 Miami 암 연구소가 포함됩니다.
이번 시험은 IDH 와일드 타입, 메틸화 음성의 교모세포종 환자를 대상으로 하여 이 공격적인 뇌암의 치료 결과를 개선하는 것을 목표로 합니다. 로피독수리딘은 FDA로부터 희귀의약품 지정을 받았습니다. 연구는 처음에 40명의 환자를 등록하고 두 가지 복용량 수준을 시험하며, 통계적 유의성을 달성하기 위해 추가로 14명의 환자를 나중에 추가합니다. Shuttle Pharma는 시험이 18에서 24개월 이내에 완료될 것으로 예상합니다.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) a élargi son essai clinique de phase 2 pour le Ropidoxuridine, un sensibilisateur aux radiations pour le traitement des patients atteints de glioblastome. L'entreprise a ajouté deux nouveaux sites, portant le total à quatre sur six sites prévus prêts à inscrire des patients. Il s'agit notamment du UVA Cancer Center, du John Theurer Cancer Center, de l'Allegheny Health Network Cancer Institute et du Miami Cancer Institute.
L'essai cible les patients atteints de glioblastome IDH wild-type et négatifs à la méthylation, dans le but d'améliorer les résultats pour ce cancer du cerveau agressif. Le Ropidoxuridine a reçu la désignation de médicament orphelin de la FDA. L'étude initialement inscrira 40 patients, testant deux niveaux de dosage, avec l'ajout ultérieur de 14 patients pour atteindre la signification statistique. Shuttle Pharma s'attend à ce que l'essai soit terminé dans 18 à 24 mois.
Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) hat seine Phase-2-Studie für Ropidoxuridin, ein Strahlensensibilisator zur Behandlung von Glioblastom-Patienten, erweitert. Das Unternehmen hat zwei weitere Standorte hinzugefügt, sodass insgesamt vier von sechs geplanten Standorten bereit sind, Patienten einzuschreiben. Dazu gehören das UVA Cancer Center, das John Theurer Cancer Center, das Allegheny Health Network Cancer Institute und das Miami Cancer Institute.
Die Studie richtet sich an IDH Wildtyp, methyliertes negatives Glioblastom-Patienten, mit dem Ziel, die Ergebnisse für diesen aggressiven Gehirntumor zu verbessern. Ropidoxuridin hat die Orphan Drug Designation von der FDA erhalten. Zu Beginn werden 40 Patienten eingeschrieben und zwei Dosierungsstufen getestet, wobei später weitere 14 Patienten hinzugefügt werden, um statistische Signifikanz zu erreichen. Shuttle Pharma erwartet, dass die Studie in 18 bis 24 Monaten abgeschlossen sein wird.
- Expansion of Phase 2 clinical trial sites to four out of six planned locations
- Orphan Drug Designation received from FDA for Ropidoxuridine
- Potential market of 400,000 patients treated for curative purposes, expected to grow by 22% in five years
- Trial design allows for determination of optimal dosage and statistical significance
- Long trial duration of 18 to 24 months
- patient pool with specific glioblastoma type (IDH wild-type, methylation negative)
- Current survival rate for target patient group is less than 12 months after diagnosis
Insights
The expansion of clinical trial sites for Shuttle Pharma's Phase 2 study of Ropidoxuridine in glioblastoma treatment is a significant development. With four out of six planned sites now ready to enroll patients, including prestigious cancer centers, this could accelerate patient recruitment and data collection. The focus on IDH wild-type, methylation negative glioblastoma patients is crucial, as this subgroup has treatment options and poor prognosis.
The two-dose randomization (1,200 mg/day vs. 960 mg/day) followed by an expansion cohort is a smart trial design. It allows for dose optimization and potentially achieving statistical significance in survival outcomes. However, the 18-24 month timeline for trial completion seems optimistic given the typically slow progression of glioblastoma trials. Investors should monitor enrollment rates and any interim analyses carefully.
Shuttle Pharma's approach with Ropidoxuridine as a radiation sensitizer for glioblastoma is intriguing. The Orphan Drug Designation provides potential market exclusivity, which is valuable in this niche. Targeting IDH wild-type, methylation negative glioblastoma is strategic, as these patients have the worst prognosis and options beyond radiation therapy.
The survival endpoint comparison to historical controls is appropriate but challenging. Glioblastoma treatment has seen incremental improvements, so ensuring the historical data is recent and matched will be important for meaningful results. The potential to improve outcomes in a disease with less than 12-month median survival is significant. However, safety will be paramount, as increasing radiation sensitivity could potentially exacerbate side effects in healthy brain tissue.
Shuttle Pharma's focus on radiation sensitizers targets a substantial market. With 400,000 patients treated annually for curative purposes and projected 22% growth over five years, the potential is significant. However, competition and market penetration will be key challenges.
The company's strategy to improve radiation therapy outcomes could position it well in the oncology market. The Orphan Drug Designation provides both market protection and potential for expedited review. Investors should note that while the glioblastoma market is relatively small, success here could pave the way for broader applications in other cancers treated with radiation. The company's pipeline and ability to expand indications will be important for long-term growth potential.
GAITHERSBURG, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today it has entered into agreements with two additional site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma. Four of the planned six trial sites are now prepared to enroll patients in the clinical trial, including the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, part of Baptist Health South Florida.
“I am pleased to report yet another key milestone in the advancement of our Phase 2 clinical trial for the treatment of patients with glioblastoma, having successfully onboarded two additional nationally recognized cancer centers,” commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. “Each of the four initial locations have completed site initiation visits and are fully ready to begin treating patients, with the final two sites set to come on board in the coming weeks. The six universities and hospitals we have selected to participate in this important clinical trial are those we deem to be most likely to treat IDH wild-type, methylation negative glioblastoma patients, the target of the clinical trial, which should allow for more rapid enrollment of the Phase 2 trial.”
Ropidoxuridine (IPdR) is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.
The Phase 2 clinical trial will enroll patients with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma. Presently, radiation is the only approved standard of care for this particular group of patients, with more than half of the patients surviving for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients on the optimal dosage allowing for the achievement of statistical significance with the end point being that of survival as compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months.
An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about
More information about the Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.
About Shuttle Pharmaceuticals
Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. For more information, please visit our website at www.shuttlepharma.com.
Safe Harbor Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning the development of our company. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the “Risk Factors” section of Shuttle Pharma’s Annual Report on Form 10-K for the year ended December 31, 2023, as amended, filed with the SEC on September 4, 2024, as well other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Shuttle Pharmaceuticals
Anatoly Dritschilo, M.D., CEO
240-403-4212
info@shuttlepharma.com
Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
shph@lythampartners.com
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